Low Plasma MBL Level is a Risk Factor for Recurrent Pregnancy Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 452
- 试验地点
- 1
- 主要终点
- Plasma MBL Level (ug/ml)
研究概览
简要总结
The present study is based on the hypothesis, that recurrent pregnancy loss (RPL) is associated with abnormal plasma mannose binding lectin (p-MBL) level. Secondarily, p-MBL level may affect the reproductive and the perinatal outcome in the first pregnancy following RPL. Thus, the present study aim to examine whether MBL should be a biomarker for women at risk for RPL and, secondarily, affect the reproductive and perinatal outcome, and thereby help clinicians identify fragile women who need intensified perinatal care.
详细描述
Recurrent pregnancy loss (RPL), defined as 3 or more consecutive pregnancy losses before 22 weeks of gestation, is a multifactorial disorder affecting 1-3% of all females of reproductive age. The underlying cause of RPL remain unknown in up to 50% of patients. Some of these patients may be affected by an aberrant immune system.
Low p-MBL levels have been associated with RPL, while relations to high p-MBL levels have been poorly studied. Reports concerning association between maternal p-MBL levels and perinatal outcomes including birth weight and gestational age are conflicting. Low p-MBL level may possess a negative effect by promoting an unfavorable immune response against foreign cells such as fetal/trophoblast cells.
This study is a single center a combined cross-sectional and prospective cohort study, that aims to investigate wether high and/or low p-MBL levels are associated with RPL (primary outcome) and whether it affects reproductive outcome in the first pregnancy following admission and the perinatal outcome in the first birth before and after admission (secondary outcome). If such associations exist, p-MBL could become an biomarker for the early identification of women with need for intensified perinatal care.
The study sample consists of Danish women admitted to the Centre for Recurrent Pregnancy Loss of Western Denmark. The study group includes 267 women with RPL. P-MBL levels in patients are compared to those of 185 female blood donors of fertile age with unknown reproductive history. The association between low p-MBL level and successful reproductive outcomes is analyzed with logistic regression adjusted for confounding variables (age, BMI and smoking). The perinatal outcomes in first birth (>22 weeks of gestation) before and after admission are compared between RPL subgroups according to their p-MBL level; low (≤500 ug/l), intermediate (501-3000 ug/l), and high (>3000 ug/l) p-MBL levels.
Female patients in the study group will have a blood sample taken at their first meeting in the the Centre for Recurrent Pregnancy Loss of Western Denmark before they become pregnant, and they will be followed until delivery of the first child after RPL, if pregnancy after RPL is achieved, or until end of study March 2021. Data on perinatal outcomes of pregnancies before and after RPL were collected at the first consultation, from hospital records, and, when needed, completed by telephone or e-mail correspondence.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women admitted to the Centre for Recurrent Pregnancy Loss of Western Denmark January 2016 to March 2020
排除标准
- •Less than 3 consecutive pregnancy losses
- •Significant uterine malformation on hydrosonography or hysteroscopy
- •Significant chromosomal abnormalities
- •Abnormal menstrual cycle length (<22 or >35 days) or irregular cycle
- •Pregnancy at first meeting in the Recurrent Miscarriage Clinic
- •Age <18 and >45 years
结局指标
主要结局
Plasma MBL Level (ug/ml)
时间窗: At first consultation. Results accessible within 3 weeks.
Manose Binding Lectin level in a blood sample
次要结局
- Participants Giving Birth After Recurrent Pregnancy Loss (RPL) to a Child With Low Birth Weight(at delivery)
- Participants Giving Birth Before RPL to a Child With Low Birth Weight(At first consultation)
- Participants Giving Birth After RPL to a Child With Very Low Birth Weight(at delivery)
- Participants Giving Birth Before RPL to a Child With Very Low Birth Weight(At first consultation)
- Patients With Emergency Caesarean Section After RPL(at delivery)
- Patients With Emergency Caesarean Section Before RPL(At first consultation)
- Patients With Elective Caesarean Section After RPL(at delivery)
- Participants With Preclampsia in Pregnancy After RPL(Developed from 20 weeks gestation and until 6 weeks postpartum. Data collected at delivery.)
- Participants With Preclampsia in Pregnancy Before RPL(Developed from 20 weeks gestation and until 6 weeks postpartum. Data collected at first consultation.)
- Patients With Elective Caesarean Section Before RPL(At first consultation)
- Patients With Severe Peripartum Hemorrhage in Birth After RPL(During delivery)
- Patients With Severe Peripartum Hemorrhage in Birth Before RPL(At first consultation)
- Patients With Moderate Peripartum Hemorrhage in Birth After RPL(During delivery)
- Patients With Moderate Peripartum Hemorrhage in Birth Before RPL(At first consultation)
- Patients With a Preterm Birth in Birth After RPL(at delivery)
- Patients With a Very Preterm Birth in Birth After RPL(at delivery)
- Gender Ratio of Children Born After RPL(At delivery)
- Patients With a Stillbirth After RPL(1 week after delivery)
- Patients With a Preterm Birth in Birth Before RPL(At first consultation)
- Gender Ratio of Children Born Before RPL(At first consultation)
- Patients With a Very Preterm Birth in Birth Before RPL(At first consultation)
- Patients With a Stillbirth Before RPL(At first consultation)
- Patients With a Liveborn After RPL(Follow up at study end.)
研究者
Caroline Nørgaard-Pedersen
MD
Aalborg University Hospital